ISO 13485 is an international standard for medical device quality management systems (MD-QMS) that was first published as EN 46001 as a European standard in 1993. The QMS standard provides a framework for managing quality and continuous improvement within an organization and its supply chain within the medical device sector. Benefits include customer satisfaction and improved internal performance.
ISO 13485 outlines 251 requirements that organizations must comply with in order to achieve 3rd-party certification. The standard is reviewed every 5 years, and updated as needed, to ensure that it remains relevant and effective for organizations of all sizes and types. The 1st edition of the ISO 13485 standard was released in 1996, the 2nd edition in 2003 and the 3rd edition in 2016. The current version of the standard “ISO 13485:2016”.
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Key Links
ISO 13485:2016 International Standard - Purchase from ISO & review accompanying resources
ISO’s Online Browsing Platform (OBP) - Access to online standards, redline changes & more
ISO 13485:2016 Medical Devices: A Practical Guide - Guidance document to the ISO 13485 Standard
ISO 14971:2019 Medical Devices Standard - Application of risk management to medical devices
ISO/TC 210 Committee Homepage - News, project status, guidance & standard revision status
Standards Published by ISO/TC 210 - Quality management and corresponding general aspects for medical devices
PUB100377 - ISO’s free companion guide to the registration scheme for ISO 13485 QMS for Medical Devices
Improving the Safety of Medical Devices by ISO/TC 210 published July 2020
Reducing the Risks of Medical Devices by ISO/TC 210 published December 2019
Overview of ISO 13485 - Medical Devices webinar presented courtesy of PECB
U.S. Food & Drug Administration (FDA) Medical Devices regulations & associated resources
FDA’s Medical Device Database a comprehensive list of data sources in the medical device sector
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 11607-1:2006 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14644 (all parts) Cleanrooms and associated controlled environments
ISO 14698 (all parts) Cleanrooms and associated controlled environments — Biocontamination control
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 19011:2018 Guidelines for auditing management systems
IEC 62366-1 Medical devices — Part 1: Application of usability engineering to medical devices
MDSAP Medical Device Single Audit Program Frequently Asked Questions (Version 016 2017-08-22)
FDA’s Code of Federal Reg. Title 21 Dept of H&HS Subchapter H - Medical Devices PART 820